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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 2 - Base Study Monovalent HPV (Type 16) Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.

Group 3 - Base Study Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension

This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.

Participant Flow for 3 periods

Period 1: Vaccination (Day 1 Through Month 7)

Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

Group 2 - Base Study Monovalent HPV (Type 16) Vaccine

Group 3 - Base Study Placebo

Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension

STARTED

2723

304

2732

0

COMPLETED

2583

290

2586

0

NOT COMPLETED

140

14

146

0

Randomized Not Vaccinated

6

0

7

0

Adverse Event

1

0

7

0

Death

0

0

1

0

Lost to Follow-up

51

6

44

0

Pregnancy

5

0

7

0

Withdrawal by Subject

59

7

62

0

Moved

14

1

18

0

Unblinded

2

0

0

0

New Medical History (Not AE)

2

0

0

0

Period 2: Follow-Up (After Month 7)

Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

Group 2 - Base Study Monovalent HPV (Type 16) Vaccine

Group 3 - Base Study Placebo

Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension

STARTED

2599 [1]

291 [1]

2607 [1]

0

COMPLETED

2353

155

1959

0

NOT COMPLETED

246

136

648

0

Subjects Continuing

34

4

35

0

Subjects in Extension

13

109

412

0

Adverse Event

1

0

0

0

Death

2

0

1

0

Lost to Follow-up

113

14

108

0

Protocol Violation

1

1

5

0

Withdrawal by Subject

40

6

51

0

Moved

32

2

28

0

Site Terminated

3

0

3

0

Travel

2

0

0

0

Visits Compressed

5

0

5

0

[1]

Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up